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Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

26. května 2016 aktualizováno: Teva Branded Pharmaceutical Products R&D, Inc.

A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma

The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

511

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy
        • Investigational Site 861
      • Homewood, Alabama, Spojené státy
        • Investigational Site 842
      • Jasper, Alabama, Spojené státy
        • Investigational Site 887
    • Arizona
      • Tucson, Arizona, Spojené státy
        • Investigational Site 809
      • Tucson, Arizona, Spojené státy
        • Investigational Site 892
    • Arkansas
      • Little Rock, Arkansas, Spojené státy
        • Investigational Site 846
    • California
      • Anaheim, California, Spojené státy
        • Investigational Site 828
      • Fresno, California, Spojené státy
        • Investigational Site 900
      • Huntington Beach, California, Spojené státy
        • Investigational Site 862
      • Los Angeles, California, Spojené státy
        • Investigational Site 852
      • Los Angeles, California, Spojené státy
        • Investigational Site 909
      • Newport Beach, California, Spojené státy
        • Investigational Site 864
      • Rancho Mirage, California, Spojené státy
        • Investigational Site 812
      • Riverside, California, Spojené státy
        • Investigational Site 808
      • Sacramento, California, Spojené státy
        • Investigational Site 804
    • Colorado
      • Centennial, Colorado, Spojené státy
        • Investigational Site 837
      • Denver, Colorado, Spojené státy
        • Investigational Site 851
      • Wheat Ridge, Colorado, Spojené státy
        • Investigational Site 832
    • Florida
      • Jacksonville, Florida, Spojené státy
        • Investigational Site 855
      • Miami, Florida, Spojené státy
        • Investigational Site 865
      • Miami, Florida, Spojené státy
        • Investigational Site 881
    • Georgia
      • Albany, Georgia, Spojené státy
        • Investigational Site 805
      • Stockbridge, Georgia, Spojené státy
        • Investigational Site 870
    • Illinois
      • Chicago, Illinois, Spojené státy
        • Investigational Site 816
      • Shiloh, Illinois, Spojené státy
        • Investigational Site 824
    • Indiana
      • Evansville, Indiana, Spojené státy
        • Investigational Site 883
      • Fort Wayne, Indiana, Spojené státy
        • Investigational Site 878
    • Kansas
      • Lenexa, Kansas, Spojené státy
        • Investigational Site 820
    • Kentucky
      • Owensboro, Kentucky, Spojené státy
        • Investigational Site 873
    • Louisiana
      • Lafayette, Louisiana, Spojené státy
        • Investigational Site 801
      • Mandeville, Louisiana, Spojené státy
        • Investigational Site 877
    • Maryland
      • White Marsh, Maryland, Spojené státy
        • Investigational Site 875
    • Massachusetts
      • Fall River, Massachusetts, Spojené státy
        • Investigational Site 871
      • North Dartmouth, Massachusetts, Spojené státy
        • Investigational Site 834
    • Michigan
      • Troy, Michigan, Spojené státy
        • Investigational Site 889
    • Missouri
      • Rolla, Missouri, Spojené státy
        • Investigational Site 838
      • St. Louis, Missouri, Spojené státy
        • Investigational Site 818
      • St. Louis, Missouri, Spojené státy
        • Investigational Site 841
    • New Mexico
      • Albuquerque, New Mexico, Spojené státy
        • Investigational Site 857
    • New York
      • Newburgh, New York, Spojené státy
        • Investigational Site 819
    • North Carolina
      • Charlotte, North Carolina, Spojené státy
        • Investigational Site 844
    • Ohio
      • Middleburg Heights, Ohio, Spojené státy
        • Investigational Site 845
    • Oklahoma
      • Tulsa, Oklahoma, Spojené státy
        • Investigational Site 810
    • Oregon
      • Ashland, Oregon, Spojené státy
        • Investigational Site 859
      • Portland, Oregon, Spojené státy
        • Investigational Site 859
    • Pennsylvania
      • Jenkintown, Pennsylvania, Spojené státy
        • Investigational Site 854
    • Rhode Island
      • Providence, Rhode Island, Spojené státy
        • Investigational Site 843
    • South Carolina
      • Florence, South Carolina, Spojené státy
        • Investigational Site 802
      • Orangeburg, South Carolina, Spojené státy
        • Investigational Site 814
      • Spartanburg, South Carolina, Spojené státy
        • Investigational Site 821
      • Spartanburg, South Carolina, Spojené státy
        • Investigational Site 829
    • Tennessee
      • Knoxville, Tennessee, Spojené státy
        • Investigational Site 850
      • Nashville, Tennessee, Spojené státy
        • Investigational Site 803
    • Texas
      • Dallas, Texas, Spojené státy
        • Investigational Site 880
      • Dickinson, Texas, Spojené státy
        • Investigational Site 858
      • Live Oak, Texas, Spojené státy
        • Investigational Site 869
      • Plano, Texas, Spojené státy
        • Investigational Site 879
    • Utah
      • Salt Lake City, Utah, Spojené státy
        • Investigational Site 847
      • West Jordan, Utah, Spojené státy
        • Investigational Site 876
    • Virginia
      • Fairfax, Virginia, Spojené státy
        • Investigational Site 840
      • Richmond, Virginia, Spojené státy
        • Investigational Site 836
    • Washington
      • Seattle, Washington, Spojené státy
        • Investigational Site 867
      • Spokane, Washington, Spojené státy
        • Investigational Site 833
      • Vancouver, Washington, Spojené státy
        • Investigational Site 904
    • Wisconsin
      • Greenfield, Wisconsin, Spojené státy
        • Investigational Site 806
      • LaCrosse, Wisconsin, Spojené státy
        • Investigational Site 823

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion criteria:

Patients are included in the study if all of the following criteria are met:

  • The patient is a man or woman, 18 through 65 years of age, with a diagnosis of asthma.
  • The patient has an ACQ score of at least 1.5.
  • At screening, the patient has airway reversibility of at least 12% to beta-agonist administration.
  • The patient is currently taking fluticasone at a dosage of at least 440 µg daily (or equivalent). Patients' baseline asthma therapy regimens (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) must be stable for 30 days before screening and continue without dosage changes throughout study.
  • Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative beta-human chorionic gonadotropin (ßHCG) result for a pregnancy test at screening (serum) and baseline (urine).
  • Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).
  • Written informed consent is obtained.
  • The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, electrocardiogram (ECG) evaluation, serum chemistry, hematology, urinalysis, and serology.
  • The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

  • The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis).
  • The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
  • The patient has known hypereosinophilic syndrome (HES).
  • The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
  • The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E [anti-IgE] mAb, methotrexate, cyclosporin, interferon-α, anti-tumor necrosis factor mAb, or omalizumab) within 6 months prior to study entry (randomization).
  • The patient is currently using or has used systemic corticosteroids (includes use of oral corticosteroids) within 30 days prior to the screening visit.
  • The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
  • The patient has any aggravating factors that are inadequately controlled, and thus would aggravate asthma symptoms (eg, gastroesophageal reflux disease).
  • The patient has participated in any investigative drug or device study within 30 days prior to screening.
  • The patient has participated in any investigative biologics study within 90 days prior to screening.
  • The patient has previously received reslizumab or other anti-hIL-5 mAbs (eg, mepolizumab).
  • The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  • The patient has a current infection or disease that may preclude assessment of asthma.
  • The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency).
  • The patient is suspected of current drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
  • The patient has presence of or suspected parasitic infestation/infection.
  • Patients may not have received any live attenuated vaccine within the 12-week period before study entry.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo
Placebo intravenous injection every 4 weeks for a total of 4 doses.
Lék: Placebo
Matching placebo administered by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).
Experimentální: Reslizumab 3.0 mg/kg
Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
Lék: Reslizumab
Reslizumab administered at a dosage of 3.0 mg/kg by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).
Ostatní jména:
  • Cinquil
  • humanizovaná monoklonální protilátka
  • CEP-38072

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set
Časové okno: Baseline (Day 1), Week 16

FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.

Data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group.
Baseline (Day 1), Week 16

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures
Časové okno: Baseline (Day 1), Weeks 4, 8, 12, 16

FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.

During study (Weeks 4, 8, 12 and 16) average value was calculated using a mixed effects model for repeated measures (MMRM) with treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as a random effect.
Baseline (Day 1), Weeks 4, 8, 12, 16
Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures
Časové okno: Baseline (Day 1), Weeks 4, 8, 12, 16

The ACQ score was measured using the ACQ-7. Six questions are-self assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.

During study (Weeks 4, 8, 12 and 16) average value was calculated from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, history of asthma exacerbation in the previous year, height, baseline value, and sex as fixed factors, and patient as a random effect.
Baseline (Day 1), Weeks 4, 8, 12, 16
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in FEV1 Subpopulation
Časové okno: Baseline (Day 1), Week 16

FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.

As with the primary outcome, data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group. However the FEV1 subpopulation includes participants with more impaired lung function (% predicted FEV1 <85% at baseline).
Baseline (Day 1), Week 16
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 4, 8, 12, and 16
Časové okno: Baseline (Day 1), Weeks 4, 8, 12, and 16
FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.
Baseline (Day 1), Weeks 4, 8, 12, and 16
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16 and Endpoint
Časové okno: Baseline (Day 1), Weeks 4, 8, 12, and 16
The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva. Positive change from baseline scores indicate improvement in asthma control.
Baseline (Day 1), Weeks 4, 8, 12, and 16
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 4, 8, 12, and 16
Časové okno: Baseline (Day 1), Weeks 4, 8, 12, and 16
The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. FV was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.
Baseline (Day 1), Weeks 4, 8, 12, and 16
Change From Baseline in the Forced Expiratory Flow at 25% to 75% of the Forced Vital Capacity (FEF25%-75%) at Weeks 4, 8, 12, and 16
Časové okno: Baseline (Day 1), Weeks 4, 8, 12, and 16
The FEF25%-75% is the forced expiratory flow at 25% to 75% of the forced vital capacity. FEF25%-75% was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.
Baseline (Day 1), Weeks 4, 8, 12, and 16
Change From Baseline in Average Daily Use of Short-Acting Beta-Agonist Therapy (SABA) at Weeks 4, 8, 12, and 16
Časové okno: Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16
SABA are used for quick relief of asthma symptoms. The number of times SABA therapy was used was assessed using 3 day recall at scheduled visits. Participants were asked to recall whether SABAs were used within 3 days of the scheduled visit and, if so, how many puffs were used. Daily use was the average of those 3 days. Negative change from baseline scores indicate improvement in asthma control.
Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16
Change From Baseline in Blood Eosinophil Counts at Weeks 4, 8, 12, 16, Follow-up (Week 28) and Endpoint
Časové okno: Baseline (Day 1), Weeks 4, 8, 12, 16, Follow-up (Week 28)
Blood eosinophil counts were measured using a standard complete blood count with differential blood test at each scheduled visit. Follow-up was performed approximately 12 weeks after the 16 week treatment period. Endpoint is the last post-baseline assessment.
Baseline (Day 1), Weeks 4, 8, 12, 16, Follow-up (Week 28)
Change From Baseline in Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12 and 16
Časové okno: Baseline (Day 1), Weeks 4, 8, 12 and 16
The ACQ score was measured using the ACQ-7. Six questions are self-assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.
Baseline (Day 1), Weeks 4, 8, 12 and 16
Participants With Treatment-Emergent Adverse Events
Časové okno: Day 1 to Week 28
An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Day 1 to Week 28
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values
Časové okno: Week 4 to Week 16

Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values during any of the lab tests conducted during the treatment period.

Significance criteria:

  • Blood urea nitrogen: >=10.71 mmol/L
  • Creatinine: >=177 μmol/L
  • Uric acid: M>=625, F>=506 μmol/L
  • Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L
  • Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L
  • GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 4-49 U/L.
  • Total bilirubin: >=34.2 μmol/L
  • Creatinine phosphokinase: >5*ULN. Normal range is 24-207 U/L.
  • White blood cells: <=3.0 or >20 10^9/L
  • Hemoglobin: M<=115, F<=95 g/dL
  • Hematocrit: M<0.37, F<0.32 L/L
  • Platelets: <=75 10^9/L
  • Absolute neutrophil count: <=1.0 10^9/L
  • Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline
Week 4 to Week 16
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values
Časové okno: Week 4 to Week 28

Data represents participants with potentially clinically significant (PCS) vital sign values during any of the treatment period exams.

Significance criteria

  • Heart rate - high: >100 and increase of >= 30 beats/minute (bpm)
  • Sitting systolic blood pressure - high: >160 and increase of >=30 mmHg
  • Sitting systolic blood pressure - low: <90 and decrease of >=30 mmHg
  • Sitting diastolic blood pressure - high: >100 and increase of >=12 mmHg
  • Sitting diastolic blood pressure - low: <50 and decrease of >=12 mmHg
  • Body temperature - high: >100.5° Fahrenheit or 38.1° Celsius and increase of >2°
  • Body temperature - low: <96.5° Fahrenheit or <35.8° Celsius
Week 4 to Week 28
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Electrocardiogram (ECG) Abnormalities
Časové okno: Week 16 or endpoint
Counts represent the number of participants with potentially clinically significant ECG abnormalities as assessed by the investigator.
Week 16 or endpoint
Participants With a Positive Anti-Reslizumab Antibody Status During Study
Časové okno: Screening (Week -3), Weeks 8 and 16

Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion at screening, weeks 8 and 16 or early withdrawal. Serum samples from patients who were treated with reslizumab were analyzed for ADA by Teva (Teva Biopharmaceuticals USA, Rockville, MD) using a validated homogeneous solution-based bridging enzyme-linked immunosorbent assay (ELISA).

Endpoint =week 16 or early withdrawal.

Counts represent the total number of participants at each time point with a positive immunogenicity test, and not 'new' participants with a positive test. An overall status of positive includes participants who had a positive ADA at any time point.
Screening (Week -3), Weeks 8 and 16

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Teva Branded Pharmaceutical Products R&D, Inc.

Vyšetřovatelé

  • Ředitel studie: Global Respiratory Clinical Research, M.D., Sponsor's Medical Expert

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2012

Primární dokončení (Aktuální)

1. srpna 2013

Dokončení studie (Aktuální)

1. srpna 2013

Termíny zápisu do studia

První předloženo

3. ledna 2012

První předloženo, které splnilo kritéria kontroly kvality

10. ledna 2012

První zveřejněno (Odhad)

12. ledna 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

27. června 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. května 2016

Naposledy ověřeno

1. května 2016

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • C38072/3084

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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